FDA Product Code
FDA Product Code DXN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1130
510(k) Clearances — 1,226 records · page 2 of 13
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223291 | Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd. | 2023-06-14 | Traditional | PDF ↗ |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | Microlife Intellectual Property GmbH | 2023-05-19 | Traditional | PDF ↗ |
| K222926 | Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | Shenzhen Yuezhongxing Technology Co., Ltd. | 2023-05-05 | Traditional | PDF ↗ |
| K221742 | CONNEQT PULSE | Atcor Medical | 2023-04-21 | Traditional | PDF ↗ |
| K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023-04-12 | Traditional | PDF ↗ |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | Famidoc Technology Company Limited | 2023-04-10 | Traditional | PDF ↗ |
| K222394 | Electronic Sphygmomanometers | Qingdao Yasee Medical Device Co., Ltd. | 2023-03-03 | Traditional | PDF ↗ |
| K222869 | Arm Blood Pressure Monitor | Andon Health Co, Ltd. | 2023-02-15 | Abbreviated | PDF ↗ |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | Microlife Intellectual Property GmbH | 2023-02-03 | Traditional | PDF ↗ |
| K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-12-01 | Traditional | PDF ↗ |
| K222160 | GUS610 Blood pressure monitor | Globalcare Medical Technology Co., Ltd. | 2022-11-22 | Traditional | PDF ↗ |
| K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022-11-07 | Traditional | PDF ↗ |
| K221372 | YUWELL Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-10-17 | Traditional | PDF ↗ |
| K221913 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2022-10-12 | Special | PDF ↗ |
| K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Inbody Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K212168 | A&D Medical UM-212BLE Blood Pressure Monitor | A&D Company, Ltd. | 2022-10-06 | Traditional | PDF ↗ |
| K220220 | Electronic Sphygmomanometer (Model: LT-P30) | Zhuhai Linte Medical Instrument Co., Ltd. | 2022-10-03 | Traditional | PDF ↗ |
| K213023 | Blood Pressure Monitor(Model:Y30001) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K221040 | Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) | Jiangxi Aicare Medical Technology Co., Ltd. | 2022-08-31 | Traditional | PDF ↗ |
| K221486 | INDEX BPM | Ya Horng Electronic Co., Ltd. | 2022-08-30 | Traditional | PDF ↗ |
| K220676 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2022-08-29 | Traditional | PDF ↗ |
| K221212 | Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. | 2022-08-26 | Traditional | PDF ↗ |
| K220886 | Upper Arm Type Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | 2022-07-27 | Traditional | PDF ↗ |
| K220651 | Wrist Type Blood Pressure Monitor | Shenzhen Jamr Medical Technology Co., Ltd. | 2022-06-30 | Traditional | PDF ↗ |
| K220106 | QardioArm 2 | Qardio, Inc. | 2022-06-15 | Traditional | PDF ↗ |
| K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | Shenzhen Finicare Co., Ltd. | 2022-05-31 | Traditional | PDF ↗ |
| K201302 | LiveOne | Livemetric (Medical) S.A. | 2022-05-04 | Traditional | PDF ↗ |
| K213699 | CareTaker Monitor App | Caretaker Medical, LLC | 2022-03-30 | Traditional | PDF ↗ |
| K213189 | Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | 2022-03-01 | Traditional | PDF ↗ |
| K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K212312 | RA-T59 Wrist blood pressure monitor | Lotusnine Medical Limited | 2022-01-27 | Traditional | PDF ↗ |
| K211532 | Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 | Yibin Junxin Electronics Technology Co., Ltd. | 2022-01-19 | Traditional | PDF ↗ |
| K212877 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2022-01-12 | Traditional | PDF ↗ |
| K212115 | Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | 2022-01-05 | Traditional | PDF ↗ |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH | 2021-11-04 | Traditional | PDF ↗ |
| K212171 | Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd. | 2021-11-01 | Traditional | PDF ↗ |
| K210563 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc. | 2021-10-15 | Traditional | PDF ↗ |
| K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021-10-01 | Traditional | PDF ↗ |
| K210152 | Automatic Digital Blood Pressure Monitor | Aviche Shandong Medical Technology Co, Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K211127 | Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM | Health & Life Co., Ltd. | 2021-09-08 | Traditional | PDF ↗ |
| K211041 | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | Shenzhen Yuezhongxing Technology Co., Ltd. | 2021-08-30 | Traditional | PDF ↗ |
| K210671 | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 | Weony (Shenzhen) Technology Co., Ltd. | 2021-08-13 | Traditional | PDF ↗ |
| K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | 2021-08-13 | Special | PDF ↗ |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | Andon Health Co, Ltd. | 2021-07-30 | Abbreviated | PDF ↗ |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2021-07-29 | Abbreviated | PDF ↗ |
| K201914 | HRVWatch-Mini Wrist Monitor | Taiwan Scientific Corporation | 2021-06-07 | Traditional | PDF ↗ |
| K210435 | Automatic Arm Electronic Blood Pressure Monitor | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-05-12 | Traditional | PDF ↗ |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor | Contec Medical Systems Co.,Ltd | 2021-04-28 | Traditional | PDF ↗ |
| K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2021-04-08 | Traditional | PDF ↗ |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare, Inc. | 2021-04-01 | Traditional | PDF ↗ |
| K202891 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2021-03-09 | Traditional | PDF ↗ |
| K201332 | Meditech ABPM-06 (BP6) | Meditech , Ltd. | 2021-02-10 | Traditional | PDF ↗ |
| K193386 | Wrist Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | 2021-01-27 | Traditional | PDF ↗ |
| K193387 | Arm Electronic Sphygmomanometer | Shenzhen Changkun Technology Co., Ltd. | 2021-01-27 | Traditional | PDF ↗ |
| K202934 | Blood Pressure Monitor | Bioland Technology, Ltd. | 2021-01-26 | Traditional | PDF ↗ |
| K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021-01-22 | Traditional | PDF ↗ |
| K200560 | InBody | Inbody Co., Ltd. | 2021-01-06 | Abbreviated | PDF ↗ |
| K202372 | Upper Arm Electronic Blood Pressure Monitor | Conmo Electronic Company Limited | 2020-12-30 | Traditional | PDF ↗ |
| K200346 | Wrist Type Blood Pressure Monitor | Avita Corporation | 2020-12-17 | Traditional | PDF ↗ |
| K202599 | Transtek Wrist Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. | 2020-12-06 | Traditional | PDF ↗ |
| K200716 | Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 2020-12-04 | Traditional | PDF ↗ |
| K200442 | InBody | Inbody Co., Ltd. | 2020-12-04 | Abbreviated | PDF ↗ |
| K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020-10-09 | Traditional | PDF ↗ |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | Bioland Technology, Ltd. | 2020-09-21 | Traditional | PDF ↗ |
| K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2020-08-20 | Special | PDF ↗ |
| K200649 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Joytech Healthcare Co. , Ltd. | 2020-08-03 | Traditional | PDF ↗ |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2020-07-23 | Traditional | PDF ↗ |
| K193456 | Arm Blood Pressure Monitor | Ningbo Ranor Medical Science & Technology Co., Ltd. | 2020-07-16 | Traditional | PDF ↗ |
| K193628 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 | Traditional | PDF ↗ |
| K193627 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020-07-12 | Traditional | PDF ↗ |
| K193624 | Automatic Upper Arm Blood Pressure Monitor | Dongguan E-Test Technology Co., Ltd. | 2020-07-10 | Traditional | PDF ↗ |
| K200437 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | 2020-06-25 | Traditional | PDF ↗ |
| K193348 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | 2020-06-25 | Traditional | PDF ↗ |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2020-06-18 | Traditional | PDF ↗ |
| K200521 | Full Automatic(NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2020-06-12 | Traditional | PDF ↗ |
| K190982 | Automatic Digital Blood Pressure Monitor | Xiamen Ants Bro Technology Co., Ltd. | 2020-05-29 | Traditional | PDF ↗ |
| K191745 | Medtronic Commander Flex | Medtronic Care Management Services | 2020-05-15 | Traditional | PDF ↗ |
| K200287 | BP-BT Kiosk | Ld Technology, LLC | 2020-05-15 | Traditional | PDF ↗ |
| K192609 | Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd. | 2020-04-21 | Traditional | PDF ↗ |
| K191894 | Upper Arm Blood Pressure Monitor | Shenzhen Zhengkang Technology Co., Ltd. | 2020-02-21 | Traditional | PDF ↗ |
| K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 | Seca GmbH & Co. KG | 2020-01-23 | Traditional | PDF ↗ |
| K192023 | Arm Blood Pressure Monitor | Truly Instrument Limited | 2019-12-23 | Abbreviated | PDF ↗ |
| K191673 | Upper Arm Blood Pressure Monitor | Famidoc Technology Company Limited | 2019-11-27 | Traditional | PDF ↗ |
| K190507 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2019-09-16 | Traditional | PDF ↗ |
| K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019-09-11 | Traditional | PDF ↗ |
| K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019-08-30 | Special | PDF ↗ |
| K191180 | Electronic Blood Pressure Monitor | Shenzhen AOJ Medical Technology Co., Ltd. | 2019-08-23 | Traditional | PDF ↗ |
| K190207 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | 2019-08-19 | Traditional | PDF ↗ |
| K190893 | Non-invasive Hemodynamic Blood Pressure Monitor | Vita-Course Technologies Co., Ltd. | 2019-08-07 | Traditional | PDF ↗ |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2019-08-02 | Traditional | PDF ↗ |
| K190886 | Non-invasive blood pressure measurement systems | Joytech Healthcare Co. , Ltd. | 2019-07-29 | Special | PDF ↗ |
| K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | Grandway Technology (Shenzhen) Limited | 2019-07-22 | Special | PDF ↗ |
| K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2019-07-10 | Special | PDF ↗ |
| K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019-07-03 | Traditional | PDF ↗ |
| K190927 | Oscillometric Blood Pressure Monitor | Rudolf Riester GmbH | 2019-06-24 | Traditional | PDF ↗ |
| K190130 | The ClearSight finger cuffs | Edwards Lifesciences, LLC | 2019-06-21 | Traditional | PDF ↗ |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Health & Life Co., Ltd. | 2019-06-13 | Special | PDF ↗ |
| K183535 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2019-06-04 | Traditional | PDF ↗ |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | Health & Life Co., Ltd. | 2019-05-20 | Special | PDF ↗ |
| K183534 | Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2019-05-16 | Abbreviated | PDF ↗ |
Product code DXN · Class II · Cardiovascular. Data: openFDA.